Urinary Stress IncontinenceTC vs ST AUSNCT02591381
Transcorporal Versus Standard Artificial Urinary Sphincter Placement
A study testing Artificial Urinary Sphincter Placement in people with Urinary Stress Incontinence, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Artificial Urinary Sphincter Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing an AUS procedure would potentially be candidates for the study
- Exclusion Criteria: There are several situations in which either a TC or ST procedure would be specifically indicated, and it would be unethical to randomize these patients to the other procedure.
- No men without erectile dysfunction
- No use of injectable agents into the corporal body
- No prior urethral surgery (Prior surgery defined as; urethroplasty, urethral sling, prior AUS placement or explantation, recto-urethral fistula closure)
- No current penile prosthesis
- No concomitant placement of penile prosthesis at the time of AUS placement
- Males under the age of 18, as well as females, are also excluded
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Randomized Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
The investigators propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the United States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff, which is the portion of the device that encircles and occludes the urethra, is typically placed directly around the urethra (i.e., "standard" placement). The cuff can erode into the urethra. Transcorporal placement has been introduced as a method to reduce the risk of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never been compared to standard placement in a randomized fashion. In the randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. The investigators will conduct the study through an established, IRB-approved multi-institutional network of surgeons. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.
Read the detailed description
Procedure/ Methods:
Patients will be identified in the urology clinic upon their standard of care visit for AUS placement. The procedures that determine whether a patient is a surgical candidate are as follows:
- Incontinence Impact Questionnaire Short Form (IIQ-7) and Urinary Incontinence Symptoms index (ISI) standardized questionnaires
- Physical examination
- Review of medical history that would preclude surgery
- Cystoscopy to evaluate and rule out stricture
- Uroflow/Post void residual to ensure adequate bladder capacity
Pre surgery work up includes:
- Urine analysis and if indicated urine culture and treatment of urinary tract infection
- Flow, post-void residual if possible
- Cystoscopy to rule out bladder neck contracture or urethral stricture
- History and physical examination
- Treatment of men with 2 days of chlorhexidine wash to the perineum
- Incontinence sexual function questionaires
- Aminogllycoside and other abx prior to surgery
- 24 hour pad weight
Post-surgery follow up:
- Routine removal of catheter within 5 days post-op
- Treatment of antibiotics post-operatively to be limited to 1 week
- Activation of AUS at 4-8 weeks post-op
- Incontinence sexual function questionnaires
- 24 hour pad weight
Routine follow ups will be conducted at 2 weeks, 6 weeks, 3 months, 6 months post-operatively, and yearly thereafter (SOC). Patient characteristics that will be collected include:
- etiology of the incontinence.
- pre-operative pad usage
- prior anti-incontinence procedures
- adjuvant therapy for prostate cancer such as radiotherapy, or other history of pelvic radiation
- post-operative urodynamic studies
- cystoscopy findings
- Conditions
- Urinary Stress Incontinence
- Being tested
- Artificial Urinary Sphincter Placement
- Keywords
- urinary stress incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Urinary Sphincter PlacementProcedure or surgery
The AUS is the gold standard for treatment of severe stress urinary incontinence, particularly in patients following surgical resection of the prostate for prostate cancer. AUSs are small devices that prevent urinary flow via compression of the urethra, thus mimicking the native urinary sphincter.
| Study group | Role | What they receive |
|---|---|---|
| STANDARD AUS Placement | Experimental | Standard placement of an artificial urinary sphincter involves a small incision made in the patient's perineum or scrotum and a fluid-filled cuff is placed around the bulbar urethra (the portion of the urethra between the bladder neck and penis). Connected to the cuff with tubing, is a balloon filled with fluid that is placed behind the pubic bone or in the space between the peritoneum and abdominal muscles. A control pump is placed in the scrotum and allows the device to cycle, thus either exerting pressure to close off the urethra or releasing pressure to allow the urethra to open and the patient to void. Receives: Procedure: Artificial Urinary Sphincter Placement |
| TRANSCORPORAL AUS Placement | Experimental | Transcorporal placement has been introduced as a way to reduce risk of erosion and involves tunneling the cuff through the erectile bodies. The same incision is made as for the standard approach, and then an incision is made in each corpus cavernosum (cylinders of tissue that allow for erection). This allows the cuff to be placed around both the urethra and through the lining of the corporal bodies, increasing the bulk of tissue behind the urethra to protect it from erosion. Receives: Procedure: Artificial Urinary Sphincter Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision or removal surgery for AUS cuff problems other than mechanical failure: these include cuff erosion, impending erosion (discretion of surgeon), persistent retention due to small cuff, urethral atrophy
Measured: Through study completion, an average of up to 1 year
Secondary outcomes (5)
Rate of post-operative urinary retention
Urinary retention defined as urinary catheter placement for more than 5 days post-op.
Measured: Up to 2-4 weeks
Change in 24 hour pad test at 3 months post-op compared to pre-op
Measured: 3 months post op
Erectile function as measured pre and post AUS placement via the Sexual Health Inventory for Men (SHIM)
Sexual health is an important part of an individual's overall physical and emotional well being. This questionnaire is designed to help identify if the patient may be experiencing erectile dysfunction.
Measured: 3 month post op, 12 month post op
Incontinence impact as measured by the Incontinence Symptom Index (ISI)
This brief questionnaire is designed to assess the severity of the patient's urinary incontinence
Measured: 3 month post op, 12 month post op
Quality of Life impact as measured by the Incontinence Impact Questionnaire--Short Form (IIQ)
Some people find that accidental urine loss may affect their activities, relationships, and feelings. The questions in this assessment refer to areas in the subjects life that may have been influenced or changed by incontinent symptoms.
Measured: 3 month post op, 12 month post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Study was started but closed prior to completion because we could not meet enrollment numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Baylor College of Medicine, University of Iowa, University of Kansas, Central Ohio Urology Group, Loyola University Chicago, Lahey Clinic, University of Washington, New York University, University of California, San Diego, University of Utah
- Responsible party
- Principal investigator, Benjamin Breyer, MD, University of California, San Francisco
- Investigators
- benjamin n breyer, MD, MAS, FAC, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591381
- Sponsor's protocol ID
- K12DK083021-AUS
- Other IDs
- K12DK083021
- Acronym
- TC vs ST AUS
- Status last verified
- May 2018
- First submitted
- 20 Oct 2015
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Haab F, Trockman BA, Zimmern PE, Leach GE. Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of followup. J Urol. 1997 Aug;158(2):435-9.
PubMed 9224318Dalkin BL, Wessells H, Cui H. A national survey of urinary and health related quality of life outcomes in men with an artificial urinary sphincter for post-radical prostatectomy incontinence. J Urol. 2003 Jan;169(1):237-9. doi: 10.1016/S0022-5347(05)64076-1.
PubMed 12478144Guralnick ML, Miller E, Toh KL, Webster GD. Transcorporal artificial urinary sphincter cuff placement in cases requiring revision for erosion and urethral atrophy. J Urol. 2002 May;167(5):2075-8; discussion 2079.
PubMed 11956443Aaronson DS, Elliott SP, McAninch JW. Transcorporal artificial urinary sphincter placement for incontinence in high-risk patients after treatment of prostate cancer. Urology. 2008 Oct;72(4):825-7. doi: 10.1016/j.urology.2008.06.065. Epub 2008 Aug 26.
PubMed 18752838
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
- ClinicalTrials.gov ID
- NCT02591381
- Acronym / sponsor ID
- TC vs ST AUS / K12DK083021-AUS
- Conditions
- Urinary Stress Incontinence
- Keywords
- urinary stress incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was started but closed prior to completion because we could not meet enrollment numbers
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Minnesota, Baylor College of Medicine, University of Iowa, University of Kansas, Central Ohio Urology Group, Loyola University Chicago, Lahey Clinic, University of Washington, New York University, University of California, San Diego, University of Utah
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the United States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff, which is the portion of the device that encircles and occludes the urethra, is typically placed directly around the urethra (i.e., "standard" placement). The cuff can erode into the urethra. Transcorporal placement has been introduced as a method to reduce the risk of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never been compared to standard placement in a randomized fashion. In the randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. The investigators will conduct the study through an established, IRB-approved multi-institutional network of surgeons. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.
Detailed description
Procedure/ Methods:
Patients will be identified in the urology clinic upon their standard of care visit for AUS placement. The procedures that determine whether a patient is a surgical candidate are as follows:
- Incontinence Impact Questionnaire Short Form (IIQ-7) and Urinary Incontinence Symptoms index (ISI) standardized questionnaires
- Physical examination
- Review of medical history that would preclude surgery
- Cystoscopy to evaluate and rule out stricture
- Uroflow/Post void residual to ensure adequate bladder capacity
Pre surgery work up includes:
- Urine analysis and if indicated urine culture and treatment of urinary tract infection
- Flow, post-void residual if possible
- Cystoscopy to rule out bladder neck contracture or urethral stricture
- History and physical examination
- Treatment of men with 2 days of chlorhexidine wash to the perineum
- Incontinence sexual function questionaires
- Aminogllycoside and other abx prior to surgery
- 24 hour pad weight
Post-surgery follow up:
- Routine removal of catheter within 5 days post-op
- Treatment of antibiotics post-operatively to be limited to 1 week
- Activation of AUS at 4-8 weeks post-op
- Incontinence sexual function questionnaires
- 24 hour pad weight
Routine follow ups will be conducted at 2 weeks, 6 weeks, 3 months, 6 months post-operatively, and yearly thereafter (SOC). Patient characteristics that will be collected include:
- etiology of the incontinence.
- pre-operative pad usage
- prior anti-incontinence procedures
- adjuvant therapy for prostate cancer such as radiotherapy, or other history of pelvic radiation
- post-operative urodynamic studies
- cystoscopy findings
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD AUS Placement | Experimental | Procedure: Artificial Urinary Sphincter PlacementStandard placement of an artificial urinary sphincter involves a small incision made in the patient's perineum or scrotum and a fluid-filled cuff is placed around the bulbar urethra (the portion of the urethra between the bladder neck and penis). Connected to the cuff with tubing, is a balloon filled with fluid that is placed behind the pubic bone or in the space between the peritoneum and abdominal muscles. A control pump is placed in the scrotum and allows the device to cycle, thus either exerting pressure to close off the urethra or releasing pressure to allow the urethra to open and the patient to void. |
| TRANSCORPORAL AUS Placement | Experimental | Procedure: Artificial Urinary Sphincter PlacementTranscorporal placement has been introduced as a way to reduce risk of erosion and involves tunneling the cuff through the erectile bodies. The same incision is made as for the standard approach, and then an incision is made in each corpus cavernosum (cylinders of tissue that allow for erection). This allows the cuff to be placed around both the urethra and through the lining of the corporal bodies, increasing the bulk of tissue behind the urethra to protect it from erosion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients undergoing an AUS procedure would potentially be candidates for the study
- Exclusion Criteria: There are several situations in which either a TC or ST procedure would be specifically indicated, and it would be unethical to randomize these patients to the other procedure.
- No men without erectile dysfunction
- No use of injectable agents into the corporal body
- No prior urethral surgery (Prior surgery defined as; urethroplasty, urethral sling, prior AUS placement or explantation, recto-urethral fistula closure)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Urinary Sphincter PlacementThe AUS is the gold standard for treatment of severe stress urinary incontinence, particularly in patients following surgical resection of the prostate for prostate cancer. AUSs are small devices that prevent urinary flow via compression of the urethra, thus mimicking the native urinary sphincter. | Procedure or surgery | STANDARD AUS Placement, TRANSCORPORAL AUS Placement |
Primary outcome
Revision or removal surgery for AUS cuff problems other than mechanical failure: these include cuff erosion, impending erosion (discretion of surgeon), persistent retention due to small cuff, urethral atrophy
Time frame: Through study completion, an average of up to 1 year
5 secondary outcomes
Rate of post-operative urinary retention
Time frame: Up to 2-4 weeks
Change in 24 hour pad test at 3 months post-op compared to pre-op
Time frame: 3 months post op
Erectile function as measured pre and post AUS placement via the Sexual Health Inventory for Men (SHIM)
Time frame: 3 month post op, 12 month post op
Incontinence impact as measured by the Incontinence Symptom Index (ISI)
Time frame: 3 month post op, 12 month post op
Quality of Life impact as measured by the Incontinence Impact Questionnaire--Short Form (IIQ)
Time frame: 3 month post op, 12 month post op
Results and safety
The study was stopped early (reason given: Study was started but closed prior to completion because we could not meet enrollment numbers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 9224318Haab F, Trockman BA, Zimmern PE, Leach GE. Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of followup. J Urol. 1997 Aug;158(2):435-9.
- Background: PubMed 12478144Dalkin BL, Wessells H, Cui H. A national survey of urinary and health related quality of life outcomes in men with an artificial urinary sphincter for post-radical prostatectomy incontinence. J Urol. 2003 Jan;169(1):237-9. doi: 10.1016/S0022-5347(05)64076-1.
- Background: PubMed 11956443Guralnick ML, Miller E, Toh KL, Webster GD. Transcorporal artificial urinary sphincter cuff placement in cases requiring revision for erosion and urethral atrophy. J Urol. 2002 May;167(5):2075-8; discussion 2079.
- Background: PubMed 18752838Aaronson DS, Elliott SP, McAninch JW. Transcorporal artificial urinary sphincter placement for incontinence in high-risk patients after treatment of prostate cancer. Urology. 2008 Oct;72(4):825-7. doi: 10.1016/j.urology.2008.06.065. Epub 2008 Aug 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
benjamin n breyer, MD, MAS, FAC principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Urinary Sphincter Placement in people with Urinary Stress Incontinence, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was started but closed prior to completion because we could not meet enrollment numbers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision or removal surgery for AUS cuff problems other than mechanical failure: these include cuff erosion, impending erosion (discretion of surgeon), persistent retention due to small cuff, urethral atrophy (time frame: Through study completion, an average of up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591381, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.